OptimalCare Study

JRCT ID: jRCT1040230051

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stable angina
• Date of first enrollment: 25/06/2023
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Difference in minimum lumen area (MLA) before and after debulking process [Time Frame: Immediately before using final device]

Secondary Outcome

1. Procedural Success
2. Acute gain
3. Creatinine Kinase (CK-MB) level
4. MACE at 12 months
5. Procedural time
6. Contrast volume

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

[Patient Background]
1. 18 years of age or older
2. Patients with stable angina
3. Patients with an indication for PCI
[Lesion Background]
1. De novo target lesion
2. Target vessel diameter of 2.25 to 4.0 mm
3. Visual stenosis >75 %
4. Calcium Angle between 90 and 360 degrees assessed by angiography or IVUS

Exclude criteria

[Patient Background]
1. Inability to provide written informed consent
2. Patients with history of myocardial infarction within the previous 1 week
3. Inability to complete 12 months follow-up
4. Inability to take antiplatelet medications
5. Inability to take OA+RA combined technique
6. Patients judged as inappropriate for this study by investigators
[Lesion Background]
1. Target lesion located in bypass graft
2. In-stent restenosis as target lesion
3. Chronic total occlusion (CTO) as target lesion

Related Information

• Primary Sponsor: Kinoshita Yoshihisa